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Serp-1 for the Treatment of Acute Coronary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00243308
Recruitment Status : Terminated (Third dose group not recruited due to slow enrollment.)
First Posted : October 21, 2005
Last Update Posted : February 6, 2009
Information provided by:
Viron Therapeutics Inc

Brief Summary:
Males and females aged 18-80 years who present with ACS (unstable angina and non ST-elevation MI) defined as one or more episodes of angina lasting at least 5 minutes in the last 24 hours before admission and greater than 0.05 mV of presumed new ST-segment depression in at least 2 contiguous ECG leads OR, angina and per confirmatory angiogram, has been scheduled for percutaneous coronary angioplasty. The primary objective of this study is to evaluate the safety of Serp-1 injection when administered in 3 daily doses to patients undergoing conventional therapy for Acute Coronary Syndrome (ACS) requiring early intervention.

Condition or disease Intervention/treatment Phase
Unstable Angina Coronary Atherosclerosis Coronary Restenosis Drug: Serine proteinase-1 (Serp-1) Phase 2

Detailed Description:
A total of 72 subjects will be enrolled, separated into 3 dose groups and centrally randomized in a 3:1 ratio of Serp-1 injection to placebo control.Subjects will receive Serp-1 by intravenous (IV) bolus injection daily for 3 days, at dose levels of 5.0, 15, and 50 ug/kg/dose or placebo (0.9% normal saline) added to any prescribed therapy for ACS. Serp-1 will be administered as a single IV bolus injection. The initial IV bolus dose is administered immediately preceding the PCI procedure with subsequent doses administered 24 and 48 hours later.Subjects will be evaluated for adverse events, serum inflammatory markers and restenosis rates at 6 months post-dose.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: A Phase 2, Multicentre, Double-Blind, Placebo-Controlled, Dose Escalating Trial of the Safety, Pharmacokinetics, and Biological Activity of 3 Consecutive Daily Doses of Serp-1 When Added to Conventional Therapy in Patients With Acute Coronary Syndromes (Non ST-Elevation Myocardial Infarction and/or Unstable Angina)
Study Start Date : October 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Primary Outcome Measures :
  1. Safety (Adverse events collected until 6 months post-dose)

Secondary Outcome Measures :
  1. Inflammatory marker analysis
  2. MACE
  3. Restenosis at 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Established diagnosis of unstable angina or NSTEMI with one or more episodes of angina in the 24 hours before hospital admission
  • Scheduled for PCI

Exclusion Criteria:

  • CABG within 6 months
  • Acute ST elevation, eligible for thrombolysis on initial examination
  • Coronary lesions with total thrombotic occlusions
  • Current immunosuppressant therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00243308

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United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-0277
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49525
Canada, British Columbia
Victoria Heart Institute
Vicotria, British Columbia, Canada, V8R 4R2
Canada, Ontario
Foothills Medical Center
Calgary, Ontario, Canada, T2N 2T9
London Health Sciences Centre
London, Ontario, Canada, N6A 5C1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Viron Therapeutics Inc
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Study Director: Alexandra Lucas, MD Chief Clinical Officer- Viron Therapeutics
Study Chair: Jean-Claude Tardif, MD Director- Montreal Heart Institute Research Centre
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00243308    
Other Study ID Numbers: Serp-1-01-002
First Posted: October 21, 2005    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009
Keywords provided by Viron Therapeutics Inc:
Anti-inflammatory agents
unstable plaque
acute coronary syndrome
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Coronary Restenosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Angina Pectoris
Chest Pain
Neurologic Manifestations
Coronary Disease
Coronary Stenosis